Freeze-dried Kale to Reduce Metabolic Risk in Saudi Subjects

NCT ID: NCT04904601

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-15
• Study Completion Date: 2022-09-28

Brief Summary

Whilst obesity represents a key risk factor for the development of metabolic disease and further premature mortality, the actual type of diet may provide the 'primary insults' for inflammation affecting systemic health in the pre-diabetic state such as obesity. Specifically, previous data indicate that a high-fat diet and/or unfavorable systemic lipid profiles can impair metabolic health which may occur via inflammatory mechanisms. The study aims to conduct a randomized interventional dietary trial with Freeze-dried Kale, as a superfood, to reduce inflammation and improve lipid profile in patients with obesity. These studies will analyze the effects of this superfood on metabolic changes among obese and non-obese Saudi women. Our hypothesis is the inclusion of Brassica into the daily diet will significantly improve metabolic health, microbiota composition, lower inflammatory insults (inflammasome), and lower microbial translocation, with resulting improvements in metabolic health. The team, therefore, proposes to examine the impact of the superfood kale on lipid function (acute and medium-term) over a 4 week dietary intervention period to assess the influence on metabolic change and biomarker changes. The team intends to utilize the expertise from a broad spectrum of specialists from plant biologists, clinical and allied health care professionals, and translational scientists, to provide a unique holistic insight into the role of nutrition for metabolic health benefits in human participants. These studies will provide us with the capacity to use a directly applicable dietary supplement, freeze-dried Kale, to improve the health of people metabolically. As this is a natural product, this will have the capability to reach the market much quicker and advance research at a much faster pace. This dietary supplement will also provide an additional measure to improve the health across the general public not just those at increased risk of disease to help provide another way to improve health among Saudis.

Detailed Description

Subjects Selection:

For this study we will recruit a total of 100 obese age matched non-diabetic Saudi women, (age 18-40 years; BMI 30-40Kg/m2) through college clinics in applied medical sciences college, KSU. The study participants exclusion criteria in brief: age under 18 or above 40 years, any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome); chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulatory like cyclosporine, azathioprine; severe depression or any psychiatric illness, claustrophobia or needle phobia.

Sample and Data Collections:

Anthropometry and body composition as well as biochemical data will be undertaken for all visits, including blood, urine and stool collection. Serum will be collected all patients for later analysis. All samples collected will be stored appropriately for biochemical analysis within the Bio-Bank facilities, in the Chair for Biomarkers of Chronic Diseases in King Saud University. All samples will be stored at -80oC following the appropriate protocol extraction methods.

Intervention:

Participants will be randomized to give either Kale (blanched freeze dried Kale) group1 or placebo (Blanched Freeze dried Peas) group2. The supplements will be given as one scoop of powder of (Kale or Green Peas) three times a day for a total of 10g/day. The follow up will be for 6 week intervention. After visit 2 will be washout period for 2 weeks, to study acute and medium effects, followed by a cross-over between the groups.

Conditions

Obesity; Metabolic Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group: Kale

This group will be given one scoop of powder of (Kale) three times a day for a total of 10g/day for 6 weeks.

Group Type: ACTIVE_COMPARATOR

Kale supplement

Intervention Type: DIETARY_SUPPLEMENT

Kale (blanched freeze-dried Kale) group1

Placebo Group: Green Peas

This group will be given one scoop of powder of (Green Peas) three times a day for a total of 10g/day for 6 weeks.

Group Type: PLACEBO_COMPARATOR

Peas supplement

Intervention Type: DIETARY_SUPPLEMENT

placebo (Blanched Freeze-dried Peas) group2

Interventions

Kale supplement

Kale (blanched freeze-dried Kale) group1

Intervention Type: DIETARY_SUPPLEMENT

Peas supplement

placebo (Blanched Freeze-dried Peas) group2

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Obese (BMI 30-40Kg/m2 and above)
• Aged 18-40 years
• Saudi nationality
• Female

Exclusion Criteria

• Age under 18 or above 40 years
• Any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, Cushing's syndrome)
• Those with chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulatory like cyclosporine, azathioprine; severe depression or any psychiatric illness, claustrophobia or needle phobia.
• Males
• Expatriates

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

King AbdulAziz City for Science and Technology

OTHER

Sponsor Role: collaborator

Chair for Biomarkers of Chronic Diseases

OTHER

Sponsor Role: lead

Responsible Party

Dr. Dara Aldisi

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Community Health Department, Applied Medical Sciences, King Saud University

Riyadh, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

20121503

Identifier Type: -

Identifier Source: org_study_id